ANN ARBOR—The European Commission has approved the sale of new cholesterol-lowering drugs from Ann Arbor-based Esperion Therapeutics Inc. (Nasdaq: ESPR).
Approved were Nilemdo, a tablet containing the new drug bempedoic acid, and Nustendi, a tablet containing both bempedoic acid and another non-statin cholesterol-reducer, ezetimibe. Bempedoic works to reduce low-density lipoprotein, the so-called bad cholesterol that can lead to arterial blockage, heart attack and stroke, by inhibiting cholesterol synthesis in the liver.
The drugs are intended for those with high cholesterol who cannot tolerate today’s statin drugs due to their side effects, including muscle pain and weakness.
“Millions of patients across the European Economic Area have needed a new daily, non-statin pill to help them achieve their LDL-C goals,” said Tim M. Mayleben, Esperion president and CEO. “For those who require additional non-statin lowering of their bad cholesterol, NILEMDO will fit easily into their daily routines whether that is with their statin or without because they are statin intolerant. Esperion is committed to finding new ways to affordably manage lipids and won’t stop until everyone can achieve their goals.”
In a clinical trial involving more than 3,600 patients, Nilemdo provided lowering of up to 28 percent compared to placebo when added onto other lipid-lowering therapies. It also reduced other cholesterols, apolipoprotein B, and total cholesterol, and reduced a biomarker of diabetes inflammation, A1c. Primary side effects of the drugs were increased uric acid in the body, extremity pain, constipation, and anemia, and most side effects were mild to moderate.
Daiichi Sankyo Europe has licensed exclusive commercialization rights to Nilemdo and Nustendi in the European MrketArea and Switzerland from Esperion. Daiichi Sankyo’s European cardiovascular commercial capabilities include more than 1,000 professionals dedicated to the commercialization of cardiovascular medicines and includes synergies with an existing portfolio of novel oral anticoagulant and antiplatelet products. Under terms of the agreement, Esperion has already received a $150 million upfront payment, will receive $150 million milestone upon first commercial sale in the territory, up to $900 million in total milestones, and tiered royalties between 15 and 25 percent.
More at www.esperion.com.
The U.S. Food and Drug Administration approved the drugs under different names for sale in the United States on Feb. 24.